Daunorubicin and Cytarabine With or Without Uproleselan in Treating Older Adult Patients With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy



Status:Recruiting
Conditions:Blood Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:60 - Any
Updated:4/4/2019
Start Date:January 16, 2019
End Date:December 1, 2025

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A Randomized Phase II/III Study of Conventional Chemotherapy +/- Uproleselan (GMI-1271) in Older Adults With Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

This phase II/III trial studies how well daunorubicin and cytarabine with or without
uproleselan works in treating older adult patients with acute myeloid leukemia receiving
intensive induction chemotherapy. Drugs used in chemotherapy, such as daunorubicin and
cytarabine, work in different ways to stop the growth of cancer cells, either by killing the
cells, by stopping them from dividing, or by stopping them from spreading. Uproleselan may
prevent cancer from returning or getting worse. Giving daunorubicin and cytarabine with
uproleselan may work better in treating patients with acute myeloid leukemia compared to
daunorubicin and cytarabine alone.

PRIMARY OBJECTIVES:

I. Compare the event-free survival (EFS) of daunorubicin, cytarabine plus uproleselan versus
daunorubicin and cytarabine in subjects >= age 60 with previously untreated acute myeloid
leukemia. (Phase II) II. Compare the overall survival (OS) of the daunorubicin, cytarabine
plus uproleselan to daunorubicin and cytarabine in this patient population. (Phase III)

SECONDARY OBJECTIVES:

I. Determine the rates of complete remission (CR), complete remission with incomplete count
recovery (CRi), complete remission with incomplete hematopoietic recovery (CRh) and
cytogenetic complete remission (CCyR) for each chemotherapy regimen.

II. Determine the overall survival (OS), and remission duration of patients for each
chemotherapy regimen.

III. Describe the frequency and severity of adverse events for patients for each chemotherapy
regimen.

IV. Describe the interaction of pretreatment disease and patient characteristics including
morphology, cytogenetics, molecular genetic features, white blood cell (WBC) count and
hemogram, and performance status on clinical outcomes.

CORRELATIVE SCIENCE OBJECTIVES:

I. Correlate specific karyotype groups (normal or various primary and secondary chromosomal
abnormalities) with clinical and laboratory parameters and with response rates, response
duration, survival and cure in patients treated with various induction and post-induction
regimens.

II. Correlate specific karyotype groups with selected molecular abnormalities and with
measurable residual disease.

III. To determine karyotype changes at end of consolidation and the influence of the type of
change (or no change) in karyotype at the end of consolidation on subsequent clinical course.

IV. To determine karyotype changes at relapse and the influence of the type of change (or no
change) in karyotype at relapse on subsequent clinical course.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP 1: INDUCTION: Patients receive daunorubicin intravenously (IV) on days 1-3 and
cytarabine via continuous intravenous infusion (CIVI) over 168 hours on days 1-7. Patients
with residual disease indicated by bone marrow examination receive a second induction
including daunorubicin IV on days 1-3 and cytarabine CIVI over 12 hours on days 1-5.

CONSOLIDATION: Patients receive cytarabine IV over 3 hours on days 1-5. Treatment repeats
every 28 days for up to 3 courses in the absence of disease progression or unacceptable
toxicity.

GROUP 2: INDUCTION: Patients receive uproleselan IV QD on day 1 and then every 12 hours on
days 2-10. Patients also receive daunorubicin IV on days 2-4 and cytrarabine CIVI over 168
hours on days 2-8 over 168 hours. Patients with residual disease indicated by bone marrow
examination receive a second induction including uprleselan IV QD on day 1 and then every 12
hours on days 2-10, daunorubicin IV on days 2-3, and cytarabine CIVI over 120 hours on days
2-6.

CONSOLIDATION: Patients who achieve a CR or CRi receive uproleselan IV QD on day 1 and every
12 hours on days 2-8 and cytarabine IV over 3 hours on days 2-6. Treatment repeats every 28
days for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 2 months for 1 year,
every 3 months in year 2, and then every 6 months for up to 5 years.

Inclusion Criteria:

- Diagnosis of acute myeloid leukemia (AML) based on 2017 World Health Organization
(WHO) criteria excluding acute promyelocytic leukemia with PML-RARA.

- Note: Patients with myeloid sarcoma without bone marrow involvement, acute
leukemia of ambiguous lineage or blast transformation of chronic myelogenous
leukemia (CML) are not eligible.

- No activating mutation in the Fms-like tyrosine kinase-3 (FLT3) defined as a ratio of
mutant to wild-type allele >= 0.05 by capillary electrophoresis or a variant allele
fraction of >= 5% by next generation sequencing from either bone marrow or peripheral
blood.

- No evidence of CNS involvement of AML.

- No prior chemotherapy for myelodysplastic syndrome (MDS) or AML including
hypomethylating agents (e.g. azacitidine and decitabine) or lenalidomide with the
following exceptions:

- Emergency leukapheresis.

- Hydroxyurea.

- Growth factor/cytokine support.

- All-trans retinoic acid (ATRA).

- Single dose of intrathecal cytarabine and/or methotrexate for patients undergoing
lumbar puncture to evaluate for CNS involvement.
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1200 Starfire Drive
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150 Entranceway Drive
Saint Peters, Missouri 63376
Principal Investigator: Geoffrey L. Uy
Phone: 800-600-3606
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Saint Peters, MO
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Sainte Genevieve, Missouri 63670
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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Sainte Genevieve, MO
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Sandpoint, Idaho 83864
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
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Sandpoint, ID
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1455 St Francis Ave
Shakopee, Minnesota 55379
(952) 428-3000
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Saint Francis Regional Medical Center St. Francis Regional Medical Center has a rich tradition of...
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Shakopee, MN
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1585 W 5th St
Sheridan, Wyoming 82801
(307) 674-5400
Principal Investigator: Benjamin T. Marchello
Phone: 406-969-6060
Welch Cancer Center People in our community don't need to leave home to find high...
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Sheridan, WY
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Springfield, Illinois 62703
Principal Investigator: Bryan A. Faller
Phone: 800-444-7541
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Springfield, IL
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801 N Rutledge St
Springfield, Illinois 62702
(217) 545-8000
Principal Investigator: Bryan A. Faller
Phone: 217-545-7929
Southern Illinois University School of Medicine At SIU School of Medicine, research includes biologically oriented...
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Springfield, IL
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701 N 1st St
Springfield, Illinois 62781
(217) 788-3000
Principal Investigator: Bryan A. Faller
Phone: 217-788-3528
Memorial Medical Center Memorial Medical Center is a Magnet-designated, acute care hospital in Springfield that...
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Springfield, IL
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630 Medical Dr
Stillwater, Minnesota 84010
(801) 299-2200
Principal Investigator: Daniel M. Anderson
Phone: 952-993-1517
Lakeview Hospital At Lakeview Hospital, our Mission is to provide the quality of healthcare we...
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Stillwater, MN
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Sullivan, Missouri 63080
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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Sullivan, MO
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Sunset Hills, Missouri 63127
Principal Investigator: Bryan A. Faller
Phone: 314-996-5569
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Sunset Hills, MO
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Swansea, Illinois 62226
Principal Investigator: Bryan A. Faller
Phone: 217-876-4740
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Swansea, IL
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7 Executive Woods Court
Swansea, Illinois 62226
Principal Investigator: Bryan A. Faller
Phone: 618-236-1000
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Swansea, IL
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Toledo, Ohio 43623
Principal Investigator: Rex B. Mowat
Phone: 419-407-1160
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Toledo, OH
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